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Lead Clinical Trial Operations Manager

2 months ago

Waltham, Massachusetts, United States Visterra Full time
Job Overview

Position Summary:
The Senior Clinical Trial Manager plays a pivotal role within the clinical operations division, facilitating the execution and oversight of clinical trials. Reporting directly to the Associate Director of Clinical Operations, this position is essential for ensuring the success of clinical studies.

Key Responsibilities:

  • Directing assigned tasks with decisiveness and sound judgment.
  • Collaborating with both internal cross-functional teams and external CROs/vendors to ensure clarity on timelines.
  • Identifying potential risks and proactively escalating them to management with proposed mitigation strategies.
  • Overseeing the document finalization process with internal and external stakeholders, ensuring that all feedback is integrated and that documents are grammatically correct and well-formatted.
  • Creating essential clinical study documents, including Informed Consent Forms (ICF), study protocols, and pharmacy manuals.
  • Ensuring timely management and completion of all clinical data, developing tracking tools and reports for the study team.
  • Preparing and managing the Trial Master File (TMF) and internal documentation.
  • Participating in regulatory audits and inspections as necessary.
  • Facilitating internal study meetings, including the preparation of agendas and minutes.
  • Assisting with budget forecasting, monitoring expenditures against the budget, and informing management of any discrepancies.
  • Providing mentorship and training to junior team members.

Qualifications:

  • Bachelor's degree in a scientific or healthcare discipline is required.
  • A minimum of seven years of clinical research experience within a pharmaceutical, biotechnology, or CRO environment.
  • In-depth knowledge of GCP/ICH Guidelines and relevant CFRs governing clinical trials.
  • Strong communication skills, both written and verbal, along with adaptability and self-motivation.
  • Ability to manage shifting priorities effectively.
  • Experience in managing direct reports.
  • Exceptional interpersonal, organizational, and multitasking abilities.
  • Meticulous attention to detail and strong problem-solving capabilities.
  • Proven ability to work effectively in a collaborative team environment.
  • Proficiency in computer applications, including Microsoft Office; familiarity with EDC and CTMS systems is advantageous.
  • Willingness to travel domestically and internationally up to 30% of the time.

About Visterra:
Visterra is a clinical-stage biotechnology firm dedicated to the development of innovative antibody-based therapies aimed at treating kidney diseases and other challenging conditions. Our proprietary technology platform allows for the design and engineering of precision antibody-based candidates that specifically target and modulate key disease mechanisms. By applying this technology to address disease targets inadequately served by conventional therapies, we are building a robust pipeline of novel treatments for patients with significant unmet medical needs.

Visterra is an equal opportunity employer, committed to fostering a diverse and inclusive workplace, and prohibits discrimination and harassment of any kind.